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硬化疗法与结扎术预防性治疗高危食管静脉曲张的前瞻性随机对照试验。

A prospective randomized controlled trial of sclerotherapy vs ligation in the prophylactic treatment of high-risk esophageal varices.

作者信息

Svoboda P, Kantorová I, Ochmann J, Kozumplík L, Marsová J

机构信息

Urazova Nemocnice, Research Center for Traumatology and Surgery of Czech Ministry of Health, Ponavka 6, 662 50 Brno, Moravia, Czech Republic.

出版信息

Surg Endosc. 1999 Jun;13(6):580-4. doi: 10.1007/s004649901045.

DOI:10.1007/s004649901045
PMID:10347295
Abstract

BACKGROUND

Endoscopic ligation (EVL) and endoscopic sclerotherapy (EIS) are both effective in the treatment of bleeding esophageal varices, but the efficacy of the two techniques in the prophylaxis of first variceal bleeding has not been investigated. The aim of this study was to investigate the frequency of first variceal bleeding, the recurrence of varices, and survival after treatment with the two techniques, as compared to a nontreated control group.

METHODS

A total of 157 patients with liver cirrhosis and advanced esophageal varices with no previous history of upper gastrointestinal bleeding were randomly assigned to either an EIS group (n = 55), an EVL group (n = 52), or a nontreated control group (n = 50). After the eradication of esophageal varices in the EIS and in EVL groups and in all control patients, the endoscopic examination was performed at 3-month intervals.

RESULTS

There were no significant differences between EIS and EVL in the eradication rate of esophageal varices (85% in the EIS group versus 81% in the EVL group). The mean number of sessions required to obtain eradication was lower in the EVL group than in the EIS group (4.8 +/- 1.8 versus 6.2 +/- 2.0; p = 0.0003), but the recurrence of esophageal varices was higher in the EVL group (31% versus 11%; p = 0.01). Total mortality was significantly lower in the EIS patients than in the controls (20% versus 38%; p = 0.04). It was also lower, but not significantly, in the EVL patients than in the controls (23% versus 38%; p = 0.10). A significant decrease in variceal bleeding was observed both in sclerotherapy cases (20%) and controls (54%; p = 0.0005) and in ligation cases and controls (29%; p = 0.01). No significant difference in bleeding episodes was observed between the sclerotherapy and ligation cases (p = 0.29). No serious complications were observed either in the EIS or EVL groups.

CONCLUSIONS

EIS and EVL are similarly effective in the prevention of first variceal bleeding. The choice between EIS and EVL depends on the skill of the endoscopic unit. For highly experienced surgeons facing no complications, sclerotherapy seems to be preferable; for all others, it is technically easier to perform ligation.

摘要

背景

内镜下套扎术(EVL)和内镜下硬化剂注射治疗(EIS)在治疗食管静脉曲张出血方面均有效,但这两种技术在预防首次静脉曲张出血方面的疗效尚未得到研究。本研究的目的是比较这两种技术与未治疗的对照组相比,首次静脉曲张出血的发生率、静脉曲张的复发率以及治疗后的生存率。

方法

总共157例肝硬化合并晚期食管静脉曲张且无上消化道出血史的患者被随机分为EIS组(n = 55)、EVL组(n = 52)或未治疗的对照组(n = 50)。在EIS组和EVL组以及所有对照组患者消除食管静脉曲张后,每隔3个月进行一次内镜检查。

结果

EIS组和EVL组在食管静脉曲张消除率方面无显著差异(EIS组为85%,EVL组为81%)。EVL组获得消除所需的平均疗程数低于EIS组(4.8±1.8对6.2±2.0;p = 0.0003),但EVL组食管静脉曲张的复发率更高(31%对11%;p = 0.01)。EIS组患者的总死亡率显著低于对照组(20%对38%;p = 0.04)。EVL组患者的总死亡率也低于对照组,但差异不显著(23%对38%;p = 0.10)。硬化剂注射治疗组(20%)和对照组(54%;p = 0.0005)以及套扎组和对照组(29%;p = 0.01)的静脉曲张出血均显著减少。硬化剂注射治疗组和套扎组之间在出血发作方面未观察到显著差异(p = 0.29)。EIS组或EVL组均未观察到严重并发症。

结论

EIS和EVL在预防首次静脉曲张出血方面同样有效。EIS和EVL之间的选择取决于内镜科室的技术水平。对于经验丰富且无并发症的外科医生,硬化剂注射治疗似乎更可取;对于其他所有人,套扎术在技术上更容易实施。

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